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EXEL Tops Q4 Earnings and Sales, Cabometyx Label Expansion in Focus
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Exelixis, Inc. (EXEL - Free Report) reported better-than-expected fourth-quarter results.
EXEL recorded earnings of 55 cents per share, which beat the Zacks Consensus Estimate of 51 cents. The company registered adjusted earnings of 33 cents per share in the year-ago quarter. The outperformance was mainly driven by higher revenues.
Including stock-based compensation expense, earnings were 48 cents per share in the reported quarter.
Find the latest EPS estimates and surprises on Zacks Earnings Calendar.
Net revenues were $566.7 million, which beat the Zacks Consensus Estimate of $563 million. The top line surged 18.1% year over year.
Shares are down in pre-market trading. Exelixis’ shares have surged 61% year to date against the industry’s decline of 11.7%.
Image Source: Zacks Investment Research
EXEL’s Q4 in Details
Net product revenues were $515.2 million, up 20% year over year. The increase was primarily driven by a rise in sales volume and average net selling price.
Cabometyx (cabozantinib) generated revenues of $512.8 million, which beat both the Zacks Consensus Estimate of $501 million and our model estimate of $508.7 million. The drug is approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma. Cometriq (cabozantinib capsules) generated $2.4 million in net product revenues for treating medullary thyroid cancer.
Collaboration revenues, comprising license and collaboration services revenues, totaled $51.5 million, up from $50.3 million in the year-ago quarter. The increase in collaboration revenues was driven by royalty revenues for the sales of cabozantinib outside of the country, generated by collaboration partners (Ipsen Pharma and Takeda).
Research and development expenses amounted to $249 million, up 1.8% year over year. The escalation was primarily related to increases in license and other collaboration costs, personnel expenses and higher manufacturing costs to support development candidates.
Selling, general and administrative expenses totaled $134.3 million, up 2.2% year over year. This was primarily related to increases in personnel expenses and stock-based compensation expenses.
In August, Exelixis announced that the board of directors authorized the repurchase of up to $500 million of its common stock. As of Dec. 31, 2024, Exelixis had repurchased $205.6 million of the company’s common stock.
EXEL’s 2024 Results
Revenues in 2024 totaled $2.17 billion, up 18.5% from the 2023 level. EPS of $2 was up from $0.90 in 2023.
Exelixis reiterated its guidance for 2025. Revenues are expected to be between $2.15 billion and $2.25 billion. Net product revenues are estimated to be in the range of $1.95-$2.05 billion. However, the current guidance excludes revenues from a potential approval of Cabometyx for the treatment of patients with previously treated advanced neuroendocrine tumors (NET).
Research and Development expenses are expected to be in the range of $925-$975 million. Selling, General & Administrative expenses are anticipated to be in the $475-$525 million range.
Key Pipeline and Regulatory Updates From EXEL
The FDA accepted EXEL’s supplemental new drug application for cabozantinib for patients with previously treated advanced pancreatic neuroendocrine tumors (pNET) and those with previously treated advanced extra-pancreatic NET (epNET). It assigned a standard review with a target action date of April 3, 2025. In January 2025, results from an expansion cohort of the phase Ib/II STELLAR-001 trial evaluating zanzalintinib alone or in combination with Tecentriq (atezolizumab) in patients with previously treated metastatic metastatic colorectal cancer were presented.
Results showed that all efficacy parameters, including objective response rate, PFS and overall survival favored the combination of zanzalintinib plus Tecentriq versus zanzalintinib monotherapy in the overall population as well as in a subgroup of patients without liver metastases.
In November 2024, Exelixis initiated the dose-escalation stage of the first-in-human phase I study of XL495 in patients with advanced solid tumors.
Exelixis has collaborated with pharma giant Merck (MRK - Free Report) to evaluate zanzalintinib in combination with its blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in a late-stage study for treating patients with head and neck squamous cell carcinoma (HNSCC).
Per the terms of the agreement, Merck will supply Keytruda for the ongoing, Exelixis-sponsored phase III STELLAR-305 study in previously untreated PD-L1 positive recurrent or metastatic HNSCC.
Merck will also sponsor a phase I/II study and two phase III studies evaluating zanzalintinib in combination with Welireg, its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in RCC. Merck will fund one of these phase III studies, and Exelixis will co-fund the phase I/II trial and the other phase III study as well as supply zanzalintinib and cabozantinib.
Exelixis’ fourth-quarter results were decent, with both the top and bottom lines beating their respective estimates. Cabometyx maintained its status as the leading TKI for RCC, both in the front-line IO+TKI market and the second-line monotherapy segment.
The potential label expansion of the drug in NET should boost sales of the drug.
EXEL’s efforts to develop other pipeline candidates look impressive.
EXEL is also evaluating XL309, a potentially best-in-class small molecule inhibitor of USP1, in a phase I study as a single agent and in combination with olaparib, a PARP1/2 inhibitor, in patients with advanced solid tumors. Exelixis has also initiated the development of XB010.
In addition, three biotherapeutics programs are targeted for clinical development in 2025, namely XB628 PD-L1-NKG2A bispecific antibody, XB064 ILT-2 monoclonal antibody and XB371 TF-topoisomerase I inhibitor ADC.
The successful development of additional drugs should broaden the company’s portfolio and reduce dependence on its lead drug, Cabometyx.
EXEL’s Zacks Rank & Stocks to Consider
Exelixis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Immunocore Holdings plc (IMCR - Free Report) and Alnylam Pharmaceuticals (ALNY - Free Report) . While IMCR sports a Zacks Rank #1 (Strong Buy) at present, ALNY carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, estimates for Immunocore’s 2024 loss per share have remained unchanged at 94 cents. Loss per share estimates for 2025 have narrowed from $1.66 to $1.62 in the past seven days.
IMCR’s earnings beat estimates in two of the trailing four quarters and missed the same in the other two, the average surprise being 25.57%.
In the past 30 days, estimates for Alnylam Pharmaceuticals’ 2024 loss per share have remained constant at 39 cents. The consensus estimate for 2025 earnings per share is currently pegged at 41 cents.
ALNY’s earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 65.67%.
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EXEL Tops Q4 Earnings and Sales, Cabometyx Label Expansion in Focus
Exelixis, Inc. (EXEL - Free Report) reported better-than-expected fourth-quarter results.
EXEL recorded earnings of 55 cents per share, which beat the Zacks Consensus Estimate of 51 cents. The company registered adjusted earnings of 33 cents per share in the year-ago quarter. The outperformance was mainly driven by higher revenues.
Including stock-based compensation expense, earnings were 48 cents per share in the reported quarter.
Find the latest EPS estimates and surprises on Zacks Earnings Calendar.
Net revenues were $566.7 million, which beat the Zacks Consensus Estimate of $563 million. The top line surged 18.1% year over year.
Shares are down in pre-market trading. Exelixis’ shares have surged 61% year to date against the industry’s decline of 11.7%.
Image Source: Zacks Investment Research
EXEL’s Q4 in Details
Net product revenues were $515.2 million, up 20% year over year. The increase was primarily driven by a rise in sales volume and average net selling price.
Cabometyx (cabozantinib) generated revenues of $512.8 million, which beat both the Zacks Consensus Estimate of $501 million and our model estimate of $508.7 million. The drug is approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma. Cometriq (cabozantinib capsules) generated $2.4 million in net product revenues for treating medullary thyroid cancer.
Collaboration revenues, comprising license and collaboration services revenues, totaled $51.5 million, up from $50.3 million in the year-ago quarter. The increase in collaboration revenues was driven by royalty revenues for the sales of cabozantinib outside of the country, generated by collaboration partners (Ipsen Pharma and Takeda).
Research and development expenses amounted to $249 million, up 1.8% year over year. The escalation was primarily related to increases in license and other collaboration costs, personnel expenses and higher manufacturing costs to support development candidates.
Selling, general and administrative expenses totaled $134.3 million, up 2.2% year over year. This was primarily related to increases in personnel expenses and stock-based compensation expenses.
In August, Exelixis announced that the board of directors authorized the repurchase of up to $500 million of its common stock. As of Dec. 31, 2024, Exelixis had repurchased $205.6 million of the company’s common stock.
EXEL’s 2024 Results
Revenues in 2024 totaled $2.17 billion, up 18.5% from the 2023 level. EPS of $2 was up from $0.90 in 2023.
These results were in line with the preliminary results reported last month.
EXEL Reiterates Its 2025 Guidance
Exelixis reiterated its guidance for 2025. Revenues are expected to be between $2.15 billion and $2.25 billion. Net product revenues are estimated to be in the range of $1.95-$2.05 billion. However, the current guidance excludes revenues from a potential approval of Cabometyx for the treatment of patients with previously treated advanced neuroendocrine tumors (NET).
Research and Development expenses are expected to be in the range of $925-$975 million. Selling, General & Administrative expenses are anticipated to be in the $475-$525 million range.
Key Pipeline and Regulatory Updates From EXEL
The FDA accepted EXEL’s supplemental new drug application for cabozantinib for patients with previously treated advanced pancreatic neuroendocrine tumors (pNET) and those with previously treated advanced extra-pancreatic NET (epNET). It assigned a standard review with a target action date of April 3, 2025.
In January 2025, results from an expansion cohort of the phase Ib/II STELLAR-001 trial evaluating zanzalintinib alone or in combination with Tecentriq (atezolizumab) in patients with previously treated metastatic metastatic colorectal cancer were presented.
Results showed that all efficacy parameters, including objective response rate, PFS and overall survival favored the combination of zanzalintinib plus Tecentriq versus zanzalintinib monotherapy in the overall population as well as in a subgroup of patients without liver metastases.
In November 2024, Exelixis initiated the dose-escalation stage of the first-in-human phase I study of XL495 in patients with advanced solid tumors.
Exelixis has collaborated with pharma giant Merck (MRK - Free Report) to evaluate zanzalintinib in combination with its blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in a late-stage study for treating patients with head and neck squamous cell carcinoma (HNSCC).
Per the terms of the agreement, Merck will supply Keytruda for the ongoing, Exelixis-sponsored phase III STELLAR-305 study in previously untreated PD-L1 positive recurrent or metastatic HNSCC.
Merck will also sponsor a phase I/II study and two phase III studies evaluating zanzalintinib in combination with Welireg, its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in RCC. Merck will fund one of these phase III studies, and Exelixis will co-fund the phase I/II trial and the other phase III study as well as supply zanzalintinib and cabozantinib.
Exelixis, Inc. Price, Consensus and EPS Surprise
Exelixis, Inc. price-consensus-eps-surprise-chart | Exelixis, Inc. Quote
Our Take on EXEL’s Q4 Performance
Exelixis’ fourth-quarter results were decent, with both the top and bottom lines beating their respective estimates. Cabometyx maintained its status as the leading TKI for RCC, both in the front-line IO+TKI market and the second-line monotherapy segment.
The potential label expansion of the drug in NET should boost sales of the drug.
EXEL’s efforts to develop other pipeline candidates look impressive.
EXEL is also evaluating XL309, a potentially best-in-class small molecule inhibitor of USP1, in a phase I study as a single agent and in combination with olaparib, a PARP1/2 inhibitor, in patients with advanced solid tumors. Exelixis has also initiated the development of XB010.
In addition, three biotherapeutics programs are targeted for clinical development in 2025, namely XB628 PD-L1-NKG2A bispecific antibody, XB064 ILT-2 monoclonal antibody and XB371 TF-topoisomerase I inhibitor ADC.
The successful development of additional drugs should broaden the company’s portfolio and reduce dependence on its lead drug, Cabometyx.
EXEL’s Zacks Rank & Stocks to Consider
Exelixis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Immunocore Holdings plc (IMCR - Free Report) and Alnylam Pharmaceuticals (ALNY - Free Report) . While IMCR sports a Zacks Rank #1 (Strong Buy) at present, ALNY carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, estimates for Immunocore’s 2024 loss per share have remained unchanged at 94 cents. Loss per share estimates for 2025 have narrowed from $1.66 to $1.62 in the past seven days.
IMCR’s earnings beat estimates in two of the trailing four quarters and missed the same in the other two, the average surprise being 25.57%.
In the past 30 days, estimates for Alnylam Pharmaceuticals’ 2024 loss per share have remained constant at 39 cents. The consensus estimate for 2025 earnings per share is currently pegged at 41 cents.
ALNY’s earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 65.67%.